A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)
This study, called FLAURA2, explores treating a specific type of non-small cell lung cancer that has a genetic change called an EGFR mutation. Researchers are investigating whether giving an oral drug, osimertinib (also known as TAGRISSO®), together with chemotherapy, is more effective than giving osimertinib on its own. Osimertinib targets these specific genetic changes, but over time, the cancer can become resistant. The aim is to see if adding chemotherapy can delay this resistance and stop the cancer from growing for longer. Around 586 patients will take part, with some receiving osimertinib alone and others receiving the combination, decided randomly by a computer.
במבט חטוף
תוצאות
תוצאות ממחקר זה
פורסם August 2024תוצאות המחקר פורסמו.
על מה המחקר הזה?
This study, known as FLAURA2, is looking into new ways to treat a specific type of lung cancer called non-small cell lung cancer. This cancer can sometimes have a particular genetic change, or 'mutation,' in a gene called EGFR. This mutation helps doctors choose the best treatments, as some drugs target it directly.
One such drug is osimertinib, which is a tablet you take by mouth. While osimertinib works well for many patients, over time, the cancer can unfortunately become resistant to it. Researchers believe that by combining osimertinib with another type of cancer treatment called chemotherapy, they might be able to delay this resistance and keep the cancer from getting worse for longer.
The main goal of this study is to find out if using osimertinib together with chemotherapy is more effective than using osimertinib on its own for people with this specific type of lung cancer. This could potentially offer a better treatment option for patients in the future.
נקודות עיקריות
- This study tries a new combination of treatments for a specific type of lung cancer using osimertinib and chemotherapy.
- It aims to see if adding chemotherapy to osimertinib can delay the cancer from getting worse.
- Around 586 patients are expected to take part.
- Treatment groups are chosen randomly, meaning you have an equal chance of receiving either treatment.
- Involves regular hospital visits for check-ups and treatment.
- The study focuses on non-small cell lung cancer with a specific EGFR genetic change.
מי עשוי להיות זכאי?
To be considered for this study, you would generally need to be at least 18 years old and have been diagnosed with a certain type of non-small cell lung cancer that has spread locally or to other parts of your body, and which cannot be treated with surgery or radiotherapy aiming for a cure. It's important that your cancer has the specific EGFR genetic change that this study is focusing on, and that you haven't been treated for this advanced lung cancer before.
Your general health needs to be good enough to participate, and a healthcare professional will check this. You should be able to carry out your daily activities with little difficulty.
There are also certain conditions that would prevent you from joining. For example, if you have certain types of brain tumours that are not stable, or a history of specific lung conditions like interstitial lung disease. The study team will review your full medical history to ensure it's safe for you to take part.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- האם אתה לפחות בן 18?
- Do you have non-small cell lung cancer that has spread locally or more widely, and cannot be cured by surgery or radiotherapy?
- Does your cancer have an EGFR genetic change?
- Are you generally well enough to go about your daily activities with little difficulty (your doctor will check this)?
- Have you not received prior treatment for your advanced lung cancer?
- Do you not have certain unstable brain tumours or a history of specific serious lung conditions?
מה כרוך בהשתתפות?
If you join this study, it will involve several stages: a 'screening' period to check if you're suitable, a 'treatment' period where you receive the study medication, and a 'follow-up' period. In the main part of the study, there's a 50/50 chance, decided randomly by a computer, that you will either receive osimertinib on its own or osimertinib with chemotherapy. You will not be able to choose which treatment group you are in.
While you are receiving the study medication, you can expect to visit the hospital about 15 times in the first year. After that, you'll have around 4 visits per year. Each visit might last between 2 and 6 hours, depending on the medical checks needed. You will also need to use appropriate contraception during the study and for a period afterwards if you are able to become pregnant or get someone pregnant.
סיכונים ותועלות פוטנציאליים
Locations (153)
- אתר מחקרמיקוד מאומתבלפלואר, ארצות הברית
- אתר מחקרמיקוד מאומתפולרטון, ארצות הברית
- אתר מחקרמיקוד מאומתלה הויה, ארצות הברית
- אתר מחקרמיקוד מאומתסנטה מוניקה, ארצות הברית
- אתר מחקרמיקוד מאומתסנטה רוזה, ארצות הברית
- אתר מחקרמיקוד מאומתWest Hollywood, United States
- אתר מחקרמיקוד מאומתוויטייר, ארצות הברית
- אתר מחקרמיקוד מאומתאורלנדו, ארצות הברית
- אתר מחקרמיקוד מאומתטמפה, ארצות הברית
- אתר מחקרמיקוד מאומתקנזס סיטי, ארצות הברית
- אתר מחקרמיקוד מאומתלואיוויל, ארצות הברית
- אתר מחקרמיקוד מאומתבוסטון, ארצות הברית
שאלות נפוצות
What is osimertinib and how does it work?
Osimertinib is a tablet medication that specifically targets a type of lung cancer with a particular genetic change called an EGFR mutation. It helps to block the signals that make cancer cells grow.
What is 'chemotherapy'?
Chemotherapy is a type of cancer treatment that uses powerful drugs to kill fast-growing cells, including cancer cells. It's often given through a drip into a vein.
מה המשמעות של 'הוקצה באופן אקראי'?
It means a computer will decide by chance which treatment you receive – either osimertinib alone or osimertinib with chemotherapy. Neither you nor your doctor can choose this.
האם אדע איזה טיפול אני מקבל?
Yes, in this study, it's expected you will know which treatment you are receiving.
כמה זמן אהיה במחקר?
The study involves a treatment period followed by a follow-up period. You could be in the study for several years, with more frequent visits initially and then fewer visits later on.
כיצד לגלות עוד
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
דיון
דיון קהילתי
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